Balance Tele-rehabilitation With Wearable Technology for Older Adults With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from Baseline in the Mini-BESTest, a 14-item test of 4 domains of balance post-rehabilitation
研究概览
简要总结
This project will determine the feasibility and efficacy of remote assessment and treatment of balance disorders in people with Parkinson's disease.
详细描述
This project consists of a virtual balance assessment which will use objective measures of balance and gait obtained with wearable sensors on the feet and waist. During a virtual assessment, the Modified Instrumented Stand and Walk Test (ISAW) will be conducted in 80 people with Parkinson's disease (PD) to predict a gold-standard, clinical in-person assessment of balance, the Mini-Balance Evaluation System Test (Mini-BESTest). For the balance rehabilitation there will be 80 participants randomized into two groups: 1) unsupervised home Agility Boot Camp (ABC) exercises (standard of care), 2) telerehabilitation with therapist conducting the ABC exercise program. Mobility during daily life will be measured using wearable sensors to explore if improvements after rehabilitation transfer to daily life mobility. The long-term goal of this project is to develop a more effective, home-based balance assessment and treatment that can be used in older adults with balance impairments to improve safe mobility during daily life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical pre- and post-testing will be carried out by a researcher who is blinded to group assignment. Scientists analyzing daily life monitoring data will also be blinded to pre-post status.
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia and one or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
- •responsive to levodopa (self-reported)
- •Hoehn & Yahr stages I-III;
- •ages 55-85 years old
- •ability to follow directions in order to participate in testing procedures and exercise classes
- •free of any medical conditions or medication that contraindicates participation in an exercise program
- •willing and able to participate in rehabilitation intervention approximately 3x/week for 4 weeks while also refraining from making changes to medications (as reasonable) or to other exercise programs during the study period.
排除标准
- •Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD, significantly affecting gait and balance (i.e., musculoskeletal disorder, vestibular problem, head injury, stroke, cardiac disease, etc.)
- •medical condition that precludes exercise
- •cognitive inability to participate in an exercise program, such as MoCA score less than or equal to 19, prior diagnosis of dementia or inability to follow directions
- •recurrent fallers, defined as those who fall more than 3 times a week (from patient and caregiver recollection)
- •excessive use of alcohol or recreational drugs
- •recent change in medication
- •inability to stand and walk for ISAW without an assistive device.
研究组 & 干预措施
Supervised Tele-Rehabilitation Home Exercise
40 participants will have tele-rehabilitation virtually with a physical therapist for 60 minutes approximately three times per week for four weeks of intervention (12 visits). Participants will also be assessed for daily life mobility for seven days pre and post intervention with wearable sensors.
干预措施: Balance Tele-Rehabilitation Agility Boot Camp (ABC) (Other)
Unsupervised Rehabilitation Home Exercise
40 participants will complete their home exercise Agility Boot Camp (ABC) program for 60 minutes approximately three times per week for four weeks of intervention (12 sessions). Participants will also be assessed for daily life mobility for seven days pre and post intervention with wearable sensors.
干预措施: Balance Tele-Rehabilitation Agility Boot Camp (ABC) (Other)
结局指标
主要结局
Change from Baseline in the Mini-BESTest, a 14-item test of 4 domains of balance post-rehabilitation
时间窗: Pre and Post rehabilitation
The Mini-BESTest, a 14-item test of 4 domains of balance, that has been well studied and is related to fall risk in people with Parkinson's disease.
次要结局
- TabCAT(Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).)
- Change from Baseline in the Patient Global Impression of Change (PGIC), a seven point scale depicting the patient's impression of improvement post-rehabilitation(after rehabilitation)
- Life Space Assessment Questionnaire(Pre and Post rehabilitation)
- Time Up and Go Test(Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).)
- Change from Baseline in the modified and standard Instrumented Stand and Walk (Modified ISAW and ISAW, respectively) tests post-rehabilitation(Pre and Post rehabilitation)
- MDS-United Parkinson's Disease Rating Scale (UPDRS) I-IV(Pre and Post rehabilitation)
- International Physical Activity Questionnaire- Short Form (IPAQ)(Pre and Post rehabilitation)
- Falls Efficacy Scale International(Pre and Post rehabilitation)
- Self-Efficacy for Exercise Scale(Pre and Post rehabilitation)
- Floor Transfer Test(Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).)
- Five-Time Sit-to-Stand Test(Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).)
- Parkinson's Disease Questionaire-39 (PDQ-39)(Pre and Post rehabilitation)
- Freezing of Gait Questionnaire (FoGQ)(Pre and Post rehabilitation)
- Wearable Sensors to Measure Daily Life Mobility(8-10 hours per day for 7 days; Pre and Post rehabilitation)
- Activities-Specific Balance Confidence(Pre and Post rehabilitation)
- 360 Degree Turn Test(Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).)
研究者
Laurie King
Professor
Oregon Health and Science University